NCT05907044已完成不适用
An Interventional, Randomized, Parallel Controlled, Investigator Initiated Study to Investigate the Safety, Immunogenicity of Bivalent RQ3027 and RQ3025 mRNA Vaccine as a Booster Dose in 3 Doses COVID-19 Vaccine-Experienced Healthy Adults
Affiliated Hospital of Yunnan University1 个研究点 分布在 1 个国家目标入组 376 人开始时间: 2023年5月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 376
- 试验地点
- 1
- 主要终点
- Number of Participants with Solicited Local and Systemic Averse Events(AEs)
研究概览
简要总结
This clinical trial aimed to gather safety and immunogenicity data in COVID-19 vaccine-experienced healthy adults. The main questions it aims to answer are:
- The neutralizing antibodies levels of bivalent mRNA vaccines RQ3027(Alpha/Beta+Omicron XBB.1.5) and RQ3025(Alpha/Beta+Omicron BA.2/4/5) and monovalent mRNA vaccine RQ3013 against the current SARS-CoV-2 circulating variant.
- The safety profile of RQ3027 and RQ3025 given as a second booster dose to COVID-19 vaccine-experienced participants 18 through 55 years of age.
- Explore the protective efficacy by documenting confirmed COVID-19 cases after vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
- •Participants 18 through 55 years of ages.
- •Participants who have received at least 3 doses COVID-19 vaccine.
- •Participants with the last prior dose being 90 or more days before Visit 1(Day 0) or recovered from COVID-19 at least 28 days.
- •Participants able to comply with all scheduled visits, laboratory tests and investigator's instruction.
排除标准
- •Women who are pregnant or breastfeeding.
- •Enrolling in or planning to participate other interventional clinical study.
- •Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening.
- •History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
- •Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
- •Continued using anticoagulants such as coumarin and related anticoagulants (i.e., warfarin) or oral anticoagulants (i.e., apixaban, rivaroxaban, dabigatran, and edoxaban).
- •Having coronary heart disease, hypertension, diabetes, chronic respiratory diseases, tumors and poorly controlled.
- •Immunocompromised or having immunosuppressive therapy.
- •Suspected or confirmed alcohol/drug dependence.
- •Investigator decide unsuitable factors for participating in clinical trials in the investigator's judgment
结局指标
主要结局
Number of Participants with Solicited Local and Systemic Averse Events(AEs)
时间窗: Up to Day 14( 7 days after vaccination)
Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5
时间窗: Day 14
次要结局
- The proportion of T cell subsets which secreted by S protein-specific cytokines (IFN-γ, IL-4)(Day 7, Day 28, Day 90, Day 180)
- Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5(Day 0, Day 7, Day 28, Day 90, Day 180)
- Number of Participants with Unsolicited Local and Systemic Averse Events(AEs)(Up to Day 180( 28 days after vaccination))
- Number of Participants with Serious AEs(SAEs)(Up to Day 180)
研究者
Jia Wei
Professor
Affiliated Hospital of Yunnan University
研究点 (1)
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